Haematology Analytical Performance Specifications
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Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
WCC | + or - 0.5 ≤ 5.0 x 109/L | + or - 10% > 5.0 x 109/L | Measurement system |
RCC | + or - 0.2 ≤ 2.0 x 1012/L | + or - 10% > 2.0 x 1012/L | Measurement system |
Hb | + or - 5 ≤ 100 g/L | + or - 5% > 100 g/L | Measurement system |
Hct | + or - 0.04 ≤ 0.20 | + or - 20% > 0.20 | Measurement system |
MCV | + or - 5 ≤ 50 fL | + or - 10% > 50 fL | Measurement system |
MCH | + or - 2 ≤ 20 pg | + or - 10% > 20 pg | Measurement system |
MCHC | + or -30 ≤ 300 g/L | + or - 10% > 300 g/L | Measurement system |
RDW-CV | + or - 2 ≤ 10% | + or - 20% > 10% | Measurement system |
PLT | + or - 25 ≤ 100 x 109/L | + or - 25% > 100 x 109/L | Measurement system |
MPV | + or - 2 ≤ 10 fL | + or - 20% > 10 fL | Measurement system |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
WCC | + or - 0.5 ≤ 5.0 x 109/L | + or - 10% > 5.0 x 109/L | Measurement system |
Neutrophils / Granulocytes | + or - 1.0 ≤ 10.0% | + or - 10% > 10.0% | Measurement system |
Lymphocytes | + or - 2.0 ≤ 10.0% | + or - 20% > 10.0% | Measurement system |
Monos / Eosinos / Basos / LUC / IG | + or - 3.0 ≤ 10.0% | + or - 30% > 10.0% | Measurement system |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Percentage | + or - 1.0 ≤ 10.0 % | + or - 10% > 10.0 % | Measurement system |
Absolute count | + or - 10 ≤ 100 | + or - 10% > 100 x109/L | Measurement system |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Percentage | + or 0.6 ≤ 2.0 % | + or - 30% > 2.0 % | Analytical principle |
Absolute count | + or 21.0 ≤ 70.0 | + or - 30% > 70.0 x109/L | Analytical principle |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
ESR | + or - 3.0 ≤ 10.0 mm/hr | + or - 30% > 10.0 mm/hr | Measurement system |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
G6PD assay | + or - 3.0 ≤ 10.0 U/g Hb | + or - 30% > 10.0 U/g Hb | Reagent |
G6PD Screen and assay Interpretation | Assessed on qualitative result | Assessed on qualitative result | N/A |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Hb A2 | + or - ≤ 0.3 2.0% | + or - 10% > 2.0% | Measurement system |
Hb F | + or - ≤ 0.5 1.50% | + or - 30% > 1.50% | Measurement system |
Hb Variant | + or - ≤ 4 20% | + or - 20% > 20% | Measurement system |
Final interpretation | Assessed on qualitative result | Assessed on qualitative result | Consensus and expert advisory |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Red cell sickling | Assessed on qualitative result | Assessed on qualitative result | N/A |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Malaria Rapid Test result | Assessed on qualitative result | Assessed on qualitative result | N/A |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
PT | + or -2.0 ≤ 10.0 sec | + or - 20% > 10.0 sec | Reagent |
INR / POC INR | + or - 0.3 ≤ 2.0 ratio | + or - 15% > 2.0 ratio | Reagent |
APTT | + or - 10 ≤ 40 sec | + or - 25% > 40 sec | Reagent |
Fibrinogen | + or - 0.20 ≤ 1.0 g/L | + or - 25% > 1.0 g/L | Reagent |
Thrombin Time | + or - 3 ≤ 12 sec | + or - 25% > 12 sec | Reagent |
Factor II, V, VII, VIII, IX, X, XI, XII | + or - 3 ≤ 10 IU/dL | + or - 30% > 10 IU/dL | Calibrator |
D-Dimer (Automated) | + or - 0.25 ≤ 0.50 DD mg/L | + or - 50% > 0.50 DD mg/L | Reagent |
D-Dimer (Automated) | + or - 0.5 ≤ 1.0 FEU mg/L | + or - 50% > 1.00 FEU mg/L | Reagent |
D-Dimer (Semi quantitative) | Assessment on interpretation | Assessment on interpretation | N/A |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
APTT | + or - 9.0 ≤ 30 sec | + or - 30% >30 sec | Reagent |
APTT Screen Ratio | + or - 0.3 ≤ 0.9 ratio | + or - 30% > 0.9 ratio | Reagent |
DRVVT screen | + or - 9.0 ≤ 30 sec | + or - 30% > 30 sec | Reagent |
DRVVT screen ratio | + or - 0.3 ≤ 0.9 ratio | + or - 30% > 0.9 ratio | Reagent |
Final interpretation | Assessment on interpretation | Assessment on interpretation | Reagent |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Protein C functional | + or - 12 ≤ 60% | + or - 20% > 60% | Reagent |
Protein S Total Antigen | + or - 10 ≤ 40% | + or - 25% > 40% | Reagent |
Protein S Free Antigen | + or - 10 ≤ 40% | + or - 25% > 40% | Reagent |
Protein S Free Functional | + or - 10 ≤ 40% | + or - 25% > 40% | Reagent |
AT Functional | + or - 10 ≤ 40% | + or - 25% > 40% | Reagent |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
APCR APTT, APTT V, APCR RVVT, RVVT V, APCR Staclot | Assessed on interpretation | Assessed on interpretation | N/A |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
FVIII:C | + or - 3 ≤ 10% | + or - 30% > 10% | Reagent |
VWF:Ag | + or - 3 ≤ 10% | + or - 30% > 10% | Reagent |
VWF:RCo | + or - 4 ≤ 10% | + or - 40% > 10% | Reagent |
VWF:CB | + or - 4 ≤ 10% | + or - 40% > 10% | Reagent |
VWF:Activity | + or - 4 ≤ 10% | + or - 40% > 10% | Reagent |
Ratios and final interpretation | Assessment on interpretation | Assessment on interpretation | Reagent |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Inhibitor level BU | Assessed on interpretation | Assessed on interpretation | Reagent deficient plasma |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Closure time | Assessed on interpretation | Assessed on interpretation | N/A |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Inhibition level | Assessed on inhibition level interpretation | Assessed on inhibition level interpretation | N/A |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
APTT | + or - 10 ≤ 40 sec | + or - 25% > 40 sec | Reagent |
Anti Xa | + or - 0.1 ≤ 0.4 U/mL | + or - 25% > 0.4 U/mL | Reagent |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
DTI | + or - 25 ≤ 100 ng/mL | + or - 25% > 100 ng/mL | Reagent |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Anti Xa | + or - 25 ≤ 100 ng/mL | + or - 25% > 100 ng/mL | Reagent |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Anti Xa | + or - 25 ≤ 100 ng/mL | + or - 25% > 100 ng/mL | Reagent |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Factor XIII | Assessment on diagnostic interpretation | Assessment on diagnostic interpretation | N/A |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Clotting Times | Assessment on final interpretation | Assessment on final interpretation | N/A |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Clotting Times | Assessment on final interpretation | Assessment on final interpretation | N/A |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Clotting Times | Clotting time interpretation | Clotting time interpretation | N/A |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
%CD34 | + or - 0.05 ≤ 0.20% | + or - 25% > 0.20% | Measurement system |
Total CD34 | + or -5 ≤ 20.0 | + or - 25% > 20.0 μL | Measurement system |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
CD markers | Assessment by Z-Score | Assessment by Z-Score | N/A |
CD marker interpretation and Final interpretation | Assessment on interpretation | Assessment on interpretation | Consensus and expert advisory |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Markers | Assessment by Z-Score | Assessment by Z-Score | N/A |
Final interpretation | Assessment on interpretation | Assessment on interpretation | Consensus and expert advisory |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Neutrophils, Total lymphocytes | + or 12 ≤ 40 % | + or 30% > 40 | N/A |
Monocytes, Eosinophils, Basophils, Lymphocytes Abnormal, other cells | + or 6 ≤ 20 % | + or 30% > 20 | N/A |
Blasts, Promyelocytes, Myelocytes, metamyelocytes, lymphocytes reactive, Nucleated red cells | + or 4 ≤ 15 % | + or 30% > 15 | N/A |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
White cell, Red and platelet morphology description | Assessed using scoring | Assessed using scoring | Consensus and expert advisory |
Diagnostic interpretation | Assessment on interpretation using terminology | Assessment on interpretation using terminology | Consensus and expert advisory |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
White cell, Red and platelet morphology description | Assessed using scoring | Assessed using scoring | Consensus and expert advisory |
Diagnostic interpretation | Assessment on interpretation using terminology | Assessment on interpretation using terminology | Consensus and expert advisory |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Blasts, Promyelocytes, Plasma cells | + or 4 ≤ 15 % | + or 30% > 15 | N/A |
Myelocytes, metamyelocytes, Neutrophils / band forms, Erythroblasts, Lymphocytes | + or 12 ≤ 40 % | + or 30% > 40 | N/A |
Monocytes, Eosinophils, Basophils, other cells | + or 6 ≤ 20 % | + or 30% > 20 | N/A |
Myeloid / Erythroid ratio | + or 1 ≤ 3.0 | + or 30% > 3 | N/A |
Diagnostic Interpretation | Assessment on interpretation using terminology | Assessment on interpretation using terminology | Consensus and expert advisory |
Analyte | Lower limit | Upper limit | Assessment category |
---|---|---|---|
Size of parasitised red cells | Assessed using scoring | Assessed using scoring | Consensus and expert advisory |
Blood film / parasite description | Assessed using scoring | Assessed using scoring | Consensus and expert advisory |
Diagnostic interpretation | Assessment on interpretation using terminology | Assessment on interpretation using terminology | Consensus and expert advisory |